针刺治疗餐后不适综合征（APDS）：一项随机对照试验的研究方案

Acupuncture for postprandial distress syndrome (APDS): study protocol for a randomized controlled trial.

作者信息

Yang Jing-Wen, Zhang Li-Wen, Shi Guang-Xia, Du Yi, Wang Jun, Zhao Jing-Jie, Cao Yan, Tu Jian-Feng, Zhang Shuai, Tan Cheng, Chen San-San, Liu Cun-Zhi

机构信息

Department of Acupuncture and Moxibustion, Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University, Beijing Key Laboratory of Acupuncture Neuromodulation, No. 23 Meishuguanhou Street, Dongcheng District, Beijing, 100010, China.

Department of Traditional Chinese Medicine, Beijing Friendship Hospital, Capital Medical University, Beijing, China.

出版信息

Trials. 2017 Nov 13;18(1):537. doi: 10.1186/s13063-017-2285-9.

DOI:10.1186/s13063-017-2285-9

PMID:29132415

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5683366/

Abstract

BACKGROUND

Postprandial distress syndrome (PDS) is referred to as meal-related functional dyspepsia (FD) and causes a reduced quality of life (QoL) for patients. Several randomized controlled trials (RCTs) have suggested that acupuncture is an effective treatment for FD, but few studies were particularly for PDS. This pilot study was designed to determine the feasibility and efficacy of acupuncture in patients with PDS characterized by postprandial fullness and early satiation according to the Rome III criteria.

METHODS

This is a multi-center, two-arm, blinded (participants), pilot RCT. Forty-two participants who meet the inclusion criteria will be randomly assigned to the verum acupuncture group or minimal acupuncture group in a 1:1 ratio. Both treatments consist of 12 sessions of 20 min duration over four weeks (three sessions per week). The primary outcome measurement is the proportion of persons who improve as assessed using the global outcome by the overall treatment effect (OTE) at end-of-treatment (EOT) (four weeks after randomization). Global assessment at weeks 8 and 16 after randomization is one of the secondary outcomes. The other secondary outcomes including symptoms, disease-specific QoL, and depression and anxiety will be assessed at weeks 4, 8, and 16 after randomization.

DISCUSSION

This pilot study will help determine the feasibility and efficacy of acupuncture in patients with PDS.

TRIAL REGISTRATION

ISRCTN Registry, ISRCTN18135146 . Registered on 7 July 2016.

摘要

背景

餐后不适综合征（PDS）被称为与进餐相关的功能性消化不良（FD），会导致患者生活质量（QoL）下降。多项随机对照试验（RCT）表明，针灸是治疗FD的有效方法，但针对PDS的研究较少。本试点研究旨在根据罗马III标准，确定针灸对以餐后饱胀和早饱为特征的PDS患者的可行性和疗效。

方法

这是一项多中心、双臂、盲法（参与者）试点RCT。42名符合纳入标准的参与者将按1:1的比例随机分配到真针灸组或最小针灸组。两种治疗均包括在四周内进行12次，每次20分钟的治疗（每周三次）。主要结局指标是在治疗结束时（随机分组后四周），根据总体治疗效果（OTE）使用整体结局评估改善的患者比例。随机分组后第8周和第16周的整体评估是次要结局之一。其他次要结局，包括症状、疾病特异性生活质量以及抑郁和焦虑，将在随机分组后第4周、第8周和第16周进行评估。